Clinical Research Operations Specialist

System One; Cleveland (OH); Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Research Operations Specialist to join their Office of Clinical Trials. This pivotal role involves managing budget negotiations and ensuring compliance with clinical trial agreements. The ideal candidate will possess strong negotiation skills and experience with clinical trial management software, particularly OnCore. You will work closely with study teams and sponsors to facilitate efficient budgetary processes, ensuring fiscal integrity and collaboration. This is a fantastic opportunity to contribute to impactful clinical research in a dynamic environment.

Qualifications

• 2+ years in clinical trial operations with a focus on budgeting.
• Experience negotiating contracts with study sponsors.

Responsibilities

• Negotiate budgetary concerns with study sponsors to uphold institutional interests.
• Provide training and support for standardized practices in budget negotiations.

Skills

Budgeting

Contract Negotiation

Communication

Clinical Trial Management Software

Regulatory Guidelines Familiarity

Education

Bachelor's degree in finance, healthcare administration, or related field

Advanced degree or certification in clinical research

Tools

OnCore

Clinical Trial Management Software

Financial Systems

Job description

Job Title:Clinical Research Operations Specialist
Location:Remote
Type:12-month contractto hire
Hourly rate: $32 to $40 an hr

Overview:
Our client is seeking a Clinical Research Operations Specialist who will bea critical member of their Office of Clinical Trials, responsible for ensuring fiscal integrity, collaboration with key partners, and consistency in the execution of clinical trial agreements. This position will oversee the application of budget charges to studies, negotiate with sponsors, and work closely with the Sponsored Projects Administration (SPA) contracts specialist.

Responsibilities:

• Apply appropriate budget charges to clinical studies in alignment with study requirements and institutional policies.
• Create the budget within OnCore
• Lead negotiations with study sponsors regarding budgetary concerns, ensuring that the institution's interests are upheld while fostering positive sponsor relationships.
• Provide study teams with the option to utilize departmental resources or the central office's fee-for-service mechanism for budget negotiations after coverage analysis.
• Serve as the primary liaison between the Office of Clinical Trials and the contracts specialist within the SPA.
• Facilitate efficient and compliant clinical trial agreement negotiations.
• Ensure that all agreements are consistent with institutional standards and regulatory requirements.
• Regardless of whether support is sourced from the department or the central office, ensure that all tools, templates, and reporting structures utilized are consistent.
• Provide training and support to departmental and central office teams to ensure standardized practices and efficient budget negotiation processes.
• Continuously evaluate and update tools and templates based on feedback and changing regulations or institutional needs.
• Maintain accurate and comprehensive records of all negotiations, agreements, and related communications.
• Generate regular reports detailing the status of ongoing negotiations, finalized agreements, and any challenges faced

Minimum Requirements:

• Bachelor's degree in finance, healthcare administration, or related field. Advanced degree or certification in clinical research preferred.
• Minimum of 2yearsexperience in clinical trial operations, with a strong emphasis on budgeting and contract negotiations.
• MUST have at least a year of experience within OnCore
• Familiarity with regulatory guidelines related to clinical trials and agreements.
• Strong negotiation skills and ability to communicate effectively with both internal teams and external sponsors.
• Proficient in clinical trial management software and financial systems

#M3

Ref: #558-Scientific